BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
|
Back to Search Results |
|
Model Number 24653 |
Device Problems
Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).
|
|
Event Description
|
It was reported that the stent was partially deployed and stretched.The 99% stenosed target lesion was located in a moderately tortuous and moderately calcified superficial femoral artery.A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected to treat the peripheral arterial disease.Pre-dilation was performed properly; however, during the procedure, the stent was difficult to deploy.As a result, the stent was stretched.The original device was used to complete the procedure.No patient complications were reported.
|
|
Manufacturer Narrative
|
E1: initial reporter state- (b)(6).Device analysis by manufacturer: returned product consisted of an eluvia self-expanding stent system with an unknown 0.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the sheath is kinked at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was x-rayed, and the proximal inner was prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.
|
|
Event Description
|
It was reported that the stent was partially deployed and stretched.The 99% stenosed target lesion was located in a moderately tortuous and moderately calcified superficial femoral artery.A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected to treat the peripheral arterial disease.Pre-dilation was performed properly; however, during the procedure, the stent was difficult to deploy.As a result, the stent was stretched.The original device was used to complete the procedure.No patient complications were reported.
|
|
Search Alerts/Recalls
|
|
|